Modular Powered Orthoses for Knee Osteoarthritis Pain
This study is testing a new type of modular, powered brace (orthosis) for your lower leg. These braces are designed to help you move more easily and reduce pain, especially if you have knee osteoarthritis (OA). The researchers believe these motorized devices can help by reducing the strain on your knee joint during daily activities. They will measure changes in your muscle effort, joint loads, and pain levels over about two months to see how well the braces work. You might be able to join if you are between 18 and 85 years old, weigh less than 300 lbs, and have a medical diagnosis of knee OA. The study is currently unclear on its recruitment status.
- Study design
- This is an interventional study planning to enroll 65 participants. It is testing a device, the modular powered orthosis.
- What's involved
- Participants will be evaluated at the beginning of the study and throughout its completion, which is expected to average two months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed through study completion, an average of 2 months.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Enhancing Voluntary Motion in Broad Patient Populations With Modular Powered Orthoses Renewal
At a glance
Conditions
NCT07673328
Where you'd take part
This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Rehab Lab
Ann Arbor, Michiganstudy coordinator listed
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
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Inclusion
Exclusion
What this trial measures
- Muscle effortBaseline and through study completion, an average of 2 months
Muscle activity will be measured by surface EMG electrodes, and EMG sites will be averaged by flexors and extensors. For each condition (no orthosis vs. powered orthosis), signals will be normalized by their peaks during the no-orthosis condition, and then averaged over cycle, repetitions, and tasks to obtain overall muscle effort (focusing on knee extension for the powered knee orthosis, hip extension and flexion for the powered hip orthosis, and ankle plantarflexion for the powered ankle orthosis).
- Joint moment loadBaseline and through study completion, an average of 2 months
Biological torques will be estimated by subtracting the assistive torques from the total joint torques computed via inverse dynamics (using OpenSim). Biological torques will be divided into flexion and extension. For each condition (no orthosis vs. powered orthosis), signals will be normalized by their peaks during the no-orthosis condition, and then averaged over cycle, repetitions, and tasks to obtain overall joint moment load (focusing on knee extension for the powered knee orthosis, hip extension and flexion for the powered hip orthosis, and ankle plantarflexion for the powered ankle orthosis).
- Pain scoreBaseline and through study completion, an average of 2 months
The Knee Injury and Osteoarthritis Outcome Score (KOOS) will be used to assess perceived pain for a multi-activity circuit test and isolated activity tests. The KOOS evaluates both short-term and long-term consequences of knee injury. It holds 42 items in 5 separately scored subscales; Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). It is an extension of the WOMAC Osteoarthritis Index. A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems as common in orthopaedic assessment scales and generic measures.